Akynzeo 300mg0.5mg capsules

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Palonosetron hydrochloride; Netupitant

MAH:

Chugai Pharma UK Ltd

INN:

Palonosetron hydrochloride; Netupitant

dosage:

500microgram ; 300mg

pharmaceutical_form:

Capsule

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 04060000; GTIN: 5060069010070

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AKYNZEO 300 MG / 0.5 MG HARD CAPSULES
Netupitant / Palonosetron
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section
4 for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Akynzeo is and what it is used for
2.
What you need to know before you take Akynzeo
3.
How to take Akynzeo
4.
Possible side effects
5.
How to store Akynzeo
6.
Contents of the pack and other information
1. WHAT AKYNZEO IS AND WHAT IT IS USED FOR
WHAT AKYNZEO IS
Akynzeo contains two medicines (‘active substances’) called:
•
netupitant
•
palonosetron.
WHAT AKYNZEO IS USED FOR
Akynzeo is used
to help prevent adults with cancer feeling sick (nausea) or being sick
(vomiting)
while having cancer treatment called ‘chemotherapy’.
HOW AKYNZEO WORKS
Chemotherapy medicines can cause the body to release substances called
serotonin and substance P.
This stimulates the vomiting centre in the brain, making you feel or
be sick. The medicines in
Akynzeo attach to the receptors in the nervous system through which
serotonin and substance P work:
netupitant (an NK
1
receptor antagonist) blocks the receptors for substance P, and
palonosetron (a 5-
HT
3
receptor antagonist) blocks certain receptors for serotonin. By
blocking the actions of substance P
and serotonin in this way, the medicines help prevent

SPC

OBJECT 1
AKYNZEO 300MG/0.5MG HARD CAPSULES
Summary of Product Characteristics Updated 06-Oct-2017 | Chugai Pharma
UK Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Akynzeo 300 mg / 0.5 mg hard capsules
2. Qualitative and quantitative composition
Each capsule contains 300 mg of netupitant, and palonosetron
hydrochloride equivalent to 0.5 mg of
palonosetron.
Excipient(s) with known effect:
Each capsule contains 7 mg of sorbitol and 20 mg of sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
Opaque gelatin capsule of size “0” (length 21.7 mm) with white
body and caramel cap with “HE1”
printed on the body. The hard capsule is filled with three tablets and
one soft capsule.
4. Clinical particulars
4.1 Therapeutic indications
Akynzeo is indicated in adults for the:
- Prevention of acute and delayed nausea and vomiting associated with
highly emetogenic cisplatin-based
cancer chemotherapy.
- Prevention of acute and delayed nausea and vomiting associated with
moderately emetogenic cancer
chemotherapy.
4.2 Posology and method of administration
Posology
_Adults_
One 300 mg / 0.5 mg capsule should be administered approximately one
hour prior to the start of each
chemotherapy cycle.
The recommended oral dexamethasone dose should be reduced by
approximately 50 % when co-
administered with Akynzeo (see section 4.5 and clinical studies
administration schedule in section 5.1).
_Elderly people_
No dosage adjustment is necessary for elderly patients. Caution should
be exercised when using this
product in patients over 75 years, due to the long half-life of the
active substances and the limited
experience in this population.
_Paediatric population _
The safety and efficacy of Akynzeo in the paediatric population have
not been establishe